Nursing Research: 杰出的研究论文

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All research has weaknesses: gaps (unexplored ideas), flaws (problems with study design), and limitations (factors that constrain the applicability of study findings). Most researchers will discuss these weaknesses, knowing these are of interest to readers as the basis for future studies. That is, where one research project ends, another begins to fill the gap, correct the flaw, or address the limitations, consequently furthering scientific advancement. Thus, although we want to do exceptional research, we also understand that research weaknesses are fruitful grounds for continuing research; weaknesses do not necessarily mean the research is unreliable or useless.

As an editor (and a researcher, scientific writer, and reviewer), I know all studies have weaknesses. Still, I strive to ensure that articles published in Nursing Research have limited weaknesses or at least well-explained ones. The challenge, which is big, is determining what is too weak versus what is, in fact, exceptional. At Nursing Research, we received over 500 papers in 2020, and we are on target for that number in 2021; because of page limitations, we will only publish about 60 articles yearly. Thus, reviewing research papers for high-quality work is critical.

Determining what is an exceptional paper takes effort. I look for specific characteristics when conducting my first review. The first characteristic I consider is author knowledge or, rather, the expression of that knowledge. All research begins with an idea or question—reviewers and readers appreciate interesting questions with answers that advance science. What researchers may fail to appreciate, however, is that questions that interest them are likely not new. Rather, much of what we study has actually been studied before. Of course, researchers may explore new variations to “old” questions, they may use new methods to address those questions, or they may study different people or variables. What I look for is a substantive, yet concisely written, review of existing research. Moreover, the review needs to include critique of the rigor of prior research and evidence that the researchers intended to address the weaknesses found in prior studies.

Next are methods, perhaps the most important characteristic to consider. There are many ways to get sloppy with methods in research reports. Researchers can fail to name and follow a research design, forget to state inclusion and exclusion criteria, or be unclear about participant recruitment, enrollment, and retention. Researchers may also fail to specify a sample size or fail to describe interventions or study measures and how they performed in the sample. Researchers may fail to specify an analytic plan or to stick with a stated plan. They may fail to address normality of the data or to report missing data, withdrawals, or dropped participants. Fortunately, science can advance with a good bit of methods messiness if we know about it. Silence about method weaknesses, however, is not good; transparent reporting of methodological mishaps is essential.

One of the most concerning methods weakness is the failure to implement adequate bias control measures. Bias is defined as systematic error caused by incorrect research methods (Higgins et al., 2011); it can be assessed by a number of tools (Spratling & Hallas, 2021). Researchers should take all appropriate actions to minimize bias. For example, measures to control bias in clinical trials include randomization of participants to interventions and control conditions, blinding of investigators (and participants) to intervention, and having a credible control condition. Bias in design is particularly problematic; what looks like a fishing expedition generally is. However, some of the most worrisome biases are the results of unplanned, undocumented, or unacknowledged protocol changes. The smallest variations in technique or procedure can lead to major differences in results. Thus, researcher clarity about what they did and why they did it is important. Reviewers and readers want to know enough to judge if divergence from a protocol materially reduced the quality or completeness of the data or changed the results. Particularly concerning are changes that affected a participant’s safety, rights, or welfare; these changes need full documentation, including a statement about how the changes were vetted through an institutional review board.

Reviewers at Nursing Research are particularly sensitive to overstated results. Researchers know to avoid the use of “trends in significance” (Nead et al., 2018), and yet I still see that statement in papers as well as statements that extend results well beyond the characteristics of the described sample. This push to make significant what is not and to apply findings to everyone whether appropriate or not often results in a paper’s negative review. Researchers also need to contextualize their results within the framework of existing knowledge. This is the hardest part of writing for me, and I suspect that is true for many others. Yet, when a discussion section is not done well, a research report is weak. Spending thoughtful time writing clearly about the meaning of research results is critical to advancing science.

There are, of course, flaws that are unrecoverable, making a research paper unpublishable. For example, we cannot publish papers of ethically questionable quality. Bad ethics is bad science. We are also unlikely to publish papers with significant conflicts of interest, particularly financial conflicts. Finally, any study involving an intervention must be preregistered on clinicaltrials.gov or a similar international trial registry (see https://www.hhs.gov/ohrp/international/clinical-trial-registries/index.html). Trial registration allows authors to document that analyses were determined in advance and are scientifically sound. All trials must be registered within 1 month of enrollment of the first participant; that has been the rule since 2017 (http://www.icmje.org/about-icmje/faqs/clinical-trials-registration/).

Perhaps, a more tricky aspect of evaluating research for high quality is theory use. We know that theory informs research in a number of ways, including providing rationale for the study, defining the aim and research questions, considering the methodological stance, developing data collection and generation tools, and providing a framework for data analysis and interpretation (Stewart & Klein, 2016). However, is theory needed for an exceptional research report? Maybe. In 1847, before the germ theory of infection was developed, Ignaz Semmelweiss suggested that by washing their hands before examinations, physicians could save the lives of many women and infants after childbirth. Semmelweiss came to this conclusion after observing that physicians’ wards produced much higher infection and death rates than midwives’ wards; midwives were willing to wash their hands, and physicians were not. Published articles showing that handwashing reduced maternal mortality to less than 1% supported Semmelweiss’ advice. However, Semmelweiss’ advice offended physicians, and they rejected it (Best & Neuhauser, 2004). Semmelweiss had no explanation for his advice about handwashing. He could describe the benefit of handwashing, but he could not explain it. He needed a theory.

At Nursing Research, we encourage authors of research reports to include an appropriate checklist of their methods. In time, these checklists will be required, and we will also ask reviewers to use checklists to guide their review. Many of these checklists can be found on the EQUATOR Network (Enhancing the Quality and Transparency of Health Research; https://www.equator-network.org/), which was created to improve the reliability and value of published health research by promoting transparent and accurate reporting of research. Specific assessment tools also exist for the critical appraisal of potential methodological flaws (i.e., Higgins et al., 2011). Critical appraisal tools also exist as a guide for evaluating research studies, typically to determine the best evidence for practice. Critical Appraisal Skills Programme checklists are useful to evaluate research studies, including qualitative studies and randomized trials (https://casp-uk.net/casp-tools-checklists/). These guidelines very briefly address many of the areas noted above, including questions about bias in research design, analysis, and reporting. The most frequently used tool for assessing risk of bias in randomized trials is the Cochrane risk of bias tool (Higgins et al., 2011).

Recently, the revised risk of bias assessment, RoB 2.0, was published (https://sites.google.com/site/riskofbiastool/welcome/rob-2-0-tool?authuser=0). This free, online tool was designed to improve efficiency of bias assessment, particularly in randomized trials. The assessment tool helps reviewers (and researchers) determine the bias risk in a trial. A study of RobotReviewer’s performance in the appraisal of clinical trials in nursing provided good results; it could certainly be an adjunct to human review (Hirt et al., 2021).

Research provides the foundation for our discipline and practice and determines its course and value. Inaccurate findings based on poorly executed methods may lead to imprecise applications and end in further errors in scientific knowledge. Publishing high-quality, exceptional research is critical for scientific advancement and for improved outcomes for persons, families, and communities, the focus of nursing science. Although a journal editor makes the final decision to accept or reject a research paper, all of us who conduct, write about, review, read, and use science in our practice or in our own research have an obligation to ensure that the highest quality of research is published.

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所有研究都有弱点：差距（未探索的想法）、缺陷（研究设计的问题）和局限性（限制研究结果适用性的因素）。大多数研究人员将讨论这些弱点，知道这些是读者感兴趣的，作为未来研究的基础。也就是说，在一个研究项目结束的地方，另一个项目开始填补空白、纠正缺陷或解决局限性，从而进一步推动科学进步。因此，尽管我们想做非凡的研究，但我们也明白研究的弱点是继续研究的富有成效的基础；弱点并不一定意味着研究不可靠或无用。

作为编辑（以及研究员、科学作家和审稿人），我知道所有研究都有弱点。尽管如此，我仍努力确保在《护理研究》中发表的文章具有有限的弱点，或者至少可以很好地解释弱点。最大的挑战是确定什么是太弱，什么是实际上异常。在Nursing Research，我们在 2020 年收到了 500 多篇论文，而我们的目标是在 2021 年达到这个数字；由于篇幅限制，我们每年只会发表大约60篇文章。因此，审查高质量工作的研究论文至关重要。

确定什么是出色的论文需要付出努力。在进行第一次审查时，我会寻找特定的特征。我考虑的第一个特征是作者的知识，或者更确切地说，是该知识的表达。所有研究都从一个想法或问题开始——审稿人和读者喜欢有趣的问题，这些问题的答案能推动科学发展。然而，研究人员可能没有意识到，他们感兴趣的问题可能并不新鲜。相反，我们研究的大部分内容实际上已经被研究过。当然，研究人员可能会探索“旧”问题的新变化，他们可能会使用新方法来解决这些问题，或者他们可能会研究不同的人或变量。我寻找的是对现有研究的实质性但简洁的评论。而且，

接下来是方法，这可能是要考虑的最重要的特征。有很多方法可以使研究报告中的方法马虎。研究人员可能无法命名和遵循研究设计，忘记说明纳入和排除标准，或者不清楚参与者的招募、登记和保留。研究人员也可能无法指定样本大小或无法描述干预或研究措施以及它们在样本中的表现。研究人员可能无法指定分析计划或坚持既定计划。他们可能无法解决数据的正常性问题，也可能无法报告缺失的数据、退出或退出的参与者。幸运的是，如果我们知道，科学可以通过一些方法混乱来推进。然而，对方法的弱点保持沉默是不好的；

最令人担忧的方法弱点之一是未能实施适当的偏见控制措施。偏差被定义为不正确的研究方法导致的系统误差（Higgins et al., 2011）；可以通过多种工具对其进行评估 ( Spratling & Hallas, 2021）。研究人员应采取一切适当的措施以尽量减少偏见。例如，在临床试验中控制偏倚的措施包括将参与者随机分配到干预和控制条件中，使研究人员（和参与者）对干预不知情，以及拥有可靠的控制条件。设计中的偏见尤其成问题；看起来像钓鱼探险的一般是。然而，一些最令人担忧的偏差是计划外、未记录或未确认的协议更改的结果。技术或程序的最小变化可能导致结果的重大差异。因此，研究人员清楚他们做了什么以及他们为什么这样做很重要。审阅者和读者想知道足够的信息来判断与协议的分歧是否实质性地降低了数据的质量或完整性或改变了结果。特别关注影响参与者安全、权利或福利的变化；这些变化需要完整的文件，包括一份关于如何通过机构审查委员会审查这些变化的声明。

Nursing Research 的审稿人对夸大的结果特别敏感。研究人员知道要避免使用“重要趋势”（Nead 等，2018)，但我仍然在论文中看到该声明以及将结果扩展到远远超出所描述样本特征的声明。这种推动使不重要的事情变得重要并将研究结果应用于每个人（无论是否合适）通常会导致论文的负面评论。研究人员还需要在现有知识的框架内将他们的结果背景化。这对我来说是写作中最难的部分，我怀疑对其他人来说也是如此。然而，当讨论部分做得不好时，研究报告就很薄弱。花深思熟虑的时间写清楚研究结果的含义对于推进科学至关重要。

当然，存在无法修复的缺陷，导致研究论文无法发表。例如，我们不能发表道德上有问题的论文。糟糕的道德是糟糕的科学。我们也不太可能发表存在重大利益冲突，尤其是财务冲突的论文。最后，涉及干预任何研究必须预先登记clinicaltrials.gov或类似的国际试验注册（见https://www.hhs.gov/ohrp/international/clinical-trial-registries/index.html）。试验注册允许作者记录分析是预先确定的并且是科学合理的。所有试验必须在第一个参与者注册后的 1 个月内注册；这是自 2017 年以来的规则（http://www.icmje.org/about-icmje/faqs/clinical-trials-registration/）。

也许，评估高质量研究的一个更棘手的方面是理论使用。我们知道理论以多种方式为研究提供信息，包括为研究提供基本原理、确定目标和研究问题、考虑方法论立场、开发数据收集和生成工具以及提供数据分析和解释框架（斯图尔特和克莱因，2016）。然而，一份出色的研究报告需要理论吗？或许。1847 年，在感染的细菌学说尚未形成之前，伊格纳兹·塞麦尔维斯 (Ignaz Semmelweiss) 提出，通过在检查前洗手，医生可以挽救许多产后妇女和婴儿的生命。Semmelweiss 在观察到医生病房比助产士病房产生更高的感染率和死亡率后得出了这个结论；助产士愿意洗手，而医生则不愿意。已发表的文章表明，洗手可将孕产妇死亡率降低到 1% 以下，支持 Semmelweiss 的建议。然而，Semmelweiss 的建议冒犯了医生，他们拒绝了（Best & Neuhauser，2004）。塞麦尔维斯没有解释他关于洗手的建议。他可以描述洗手的好处，但他无法解释。他需要一个理论。

在护理研究，我们鼓励研究报告的作者包括他们的方法的适当清单。随着时间的推移，这些清单将是必需的，我们也会要求审稿人使用清单来指导他们的审查。EQUATOR 网络（提高卫生研究的质量和透明度；https: //www.eqator-network.org/）上可以找到其中的许多清单，该网络的创建是为了通过促进已发表的卫生研究的可靠性和价值透明和准确的研究报告。还存在用于批判性评估潜在方法缺陷的特定评估工具（即Higgins 等，2011）。批判性评估工具也可作为评估研究的指南，通常用于确定实践的最佳证据。关键评估技能计划清单可用于评估研究，包括定性研究和随机试验 ( https://casp-uk.net/casp-tools-checklists/ )。这些指南非常简要地解决了上述许多领域，包括有关研究设计、分析和报告中的偏见的问题。在随机试验中评估偏倚风险最常用的工具是 Cochrane 偏倚风险工具 ( Higgins et al., 2011 )。

最近，修订后的偏倚风险评估 RoB 2.0 发布（https://sites.google.com/site/riskofbiastool/welcome/rob-2-0-tool?authuser=0）。这个免费的在线工具旨在提高偏倚评估的效率，尤其是在随机试验中。评估工具可帮助审阅者（和研究人员）确定试验中的偏倚风险。RobotReviewer在护理临床试验评估中的表现研究提供了良好的结果；它当然可以作为人工审查的辅助手段（Hirt 等人，2021 年）。

研究为我们的学科和实践奠定了基础，并决定了其课程和价值。基于执行不力的方法而得出的不准确结果可能会导致应用不精确，并最终导致科学知识的进一步错误。发表高质量、杰出的研究对于科学进步和改善个人、家庭和社区的结果至关重要，这是护理科学的重点。尽管期刊编辑做出接受或拒绝研究论文的最终决定，但在我们的实践或我们自己的研究中进行、撰写、评论、阅读和使用科学的所有人都有义务确保最高质量的研究发表。

原文链接：

https://journals.lww.com/nursingresearchonline/Fulltext/2021/11000/Exceptional_Research_Papers.1.aspx

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